Computer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with disease modifying antirheumatic drugs (DMARDs)?

ISRCTN	ISRCTN70365169
DOI	https://doi.org/10.1186/ISRCTN70365169
Protocol serial number	N/A
Sponsor	University Medical Center Utrecht
Funders	University Medical Center Utrecht, Abbott Laboratories

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A.C.A. Marijnissen
Scientific

University Medical Center Utrecht (UMCU)
Department of Rheumatology and Clinical Immunology
F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 2509758
Email	a.c.a.marijnissen@umcutrecht.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Computer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with disease modifying antirheumatic drugs (DMARDs)?
Study acronym	CAMERA-II
Study objectives	Prednisone inhibits progression of joint damage in early RA-patients, even when intensive treatment, according to a strict computer-assisted protocol, is applied.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Rheumatoid arthritis (RA)
Intervention	10 mg of prednisolone daily versus placebo in addition to DMARDs. Two year study.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Prednisone and DMARDs
Primary outcome measure(s)	Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method.
Key secondary outcome measure(s)	Number of patients in remission, in which remission is defined as: 1. Number of swollen joints = 0 2. Plus at least two out of three following criteria: 2.a. Number of swollen joints <3 2.b. Erythrocyte sedimentation rate (ESR) <20 mm/1st hour 2.c. Visual analogue scale (VAS) of general well being <20 mm
Completion date	01/04/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	220
Key inclusion criteria	1. Rheumatoid Arthritis, defined according to the revised American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis 2. A disease duration of less than 1 year, estimated by the rheumatologist 3. Age >18 years 4. No previous treatment with DMARDs or oral glucocorticoids 5. Written informed consent by the patient
Key exclusion criteria	1. Abnormal renal function (Cockroft <75 ml/min) 2. Abnormal liver function (aspartate aminotransferase [ASAT]/alanine aminotransferase [ALAT] >2 x normal), active or recent hepatitis, cirrhosis 3. Major co-morbidities like malignancies, severe diabetic mellitus, severe infections, severe cardio and/or respiratory diseases 4. Leukopenia and/or thrombocytopenia 5. Inadequate birth control contraception, pregnancy, and/or breastfeeding 6. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study 7. Alcohol intake >2 units per day or drug abuse, presently or in the past 8. Psychiatric or mental disorders which makes adherence to the study protocol impossible 9. Taking part in another clinical trial 10. Osteoporotic vertebral fractures
Date of first enrolment	01/04/2003
Date of final enrolment	01/04/2007

University Medical Center Utrecht (UMCU)

Utrecht
3508 GA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/03/2012		Yes	No
Results article	results	01/01/2013		Yes	No
Results article	results	09/09/2020	11/09/2020	Yes	No

11/09/2020: Publication reference added.